Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval (Happy-Fiv)

Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?

Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.

HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.

Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.

Study Overview

• Status: Completed
• Conditions: Fertilization in Vitro
• Intervention / Treatment: Drug: Propofol; Drug: Sufentanil; Device: HappyMed Video Glasses

Detailed Description

Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.

After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Suresnes, Île-de-France Region, France, 92151
      • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
• Contactable by phone the day after the procedure.
• Consent for participation
• Affiliation to the social security system

Exclusion Criteria:

• Corneal or conjunctival diseases in progress,
• Claustrophobia
• Patients under protection of the adults (guardianship, curators or safeguard of justice)
• Communication difficulties or neuropsychiatric disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; Sedation according to Dixon's up-and-down method.	Drug: Propofol; The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.; Drug: Sufentanil; 0.1 µg/kg
Experimental: Audiovisual distraction; Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.	Drug: Propofol; The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.; Drug: Sufentanil; 0.1 µg/kg; Device: HappyMed Video Glasses; HappyMed allows the immersion of patients in films, cartoons or concerts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable	An up and down method will define the CP 50 in each group.	Intraoperative period : from the start of anaesthesia to the end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects due to audiovisual distraction	Onset of vertigo, nausea or headaches	4 hours
Patient comfort during propofol injection	Comfort behavior scale : it incorporates three categories of behavior : Facial expression (0=relaxed ; 1= frowning ; 2=grimacing) ; Verbal response (0=none ; 1= moans ; 2=verbal protest) ; Arm movement (0=none ; 1=medium ; 2=strong). Each scored on a 0-2-point scale so that the total score ranges from 0 to 6.	30 minutes
Complications due to anaesthesia	Occurence of desaturation event (SpO2< 92%), respiratory distress event (RR<10 breaths per minute) or bronchospasm.	up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)
Resumption of walking	Duration between the end of the procedure and the standing position.	12 hours
Health staff satisfaction	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).	2 hours
Patient satisfaction	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).	4 hours
Resuming activities of daily living	Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).	24 hours

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Publications and helpful links

General Publications

• Trou B, Pirtea P, Ma S, Aime I, Gross T, Kennel T, Jean-Marc A, Fischler M, Squara P, Le Guen M. Impact of pre-operative audiovisual distraction on consumption of hypnotics during transvaginal oocyte retrieval: A randomised controlled trial. Eur J Anaesthesiol. 2023 Aug 1;40(8):608-610. doi: 10.1097/EJA.0000000000001866. Epub 2023 Jun 22. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sedation; Oocyte retrieval
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Piperidines; Phenols; Benzene Derivatives; Fentanyl; Propofol; Sufentanil
• Other Study ID Numbers: 2019/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No